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Wednesday, February 14, 2018

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

Advances in technology are leading to a host of innovations around reducing and detecting concussions.

Today, the FDA authorized the marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults.

The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.

The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.